Fed Study of Metoprolol Tartrate Tablets 100 mg and Lopressor® 100 mg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The objective of this study was to investigate the bioequivalence of Mylan's metoprolol tartrate tablets to Novartis's Lopressor® tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.

Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior to dosing of each study period. If dosing is scheduled for a Sunday or Monday, the beta-HCG pregnancy test should be given within 48 hours prior to dosing for that study period. An additional beta-HCG pregnancy test will be performed upon completion of the study.

Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapy are permitted in this study. Acceptable forms of contraception include the following:

intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or

barrier methods containing or used in conjunction with a spermicidal agent, or

surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.

During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.

Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).

All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion Criteria:

Institutionalized subjects will not be used.

Social Habits:

Use of any tobacco products.

Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.

Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.

Any recent, significant change in dietary or exercise habits.

Medications:

Use of any medication within the 14 days prior to the initial dose of study medication. (This includes oral contraceptives and hormonal replacement therapy.)

Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. (This includes oral contraceptives and hormonal replacement therapy.)